Protocol Template [doc]
This template contains the elements of a complete protocol and is recommended as means to present the research rationale, procedures and methodology in a streamlined and efficient manner to the IRB.
Invitation to Participate-- Letter or Script (Exempt Review) [doc]
In many research studies, a formal signed consent document is not necessary or appropriate. Studies that qualify for Exempt Review (e.g. surveys, questionnaires, interviews or focus groups) should obtain the subjects agreement to participate using a less formal invitation. The format may vary depending on the means for delivering the research material. For a written survey, a cover letter or information sheet is appropriate. For interviews and focus groups, an oral script and/or letter may serve best.
Informed Consent Form (Expedited /Full Board Review) [doc]
The informed consent form (ICF) template contains the basic elements of informed consent and is recommended as a starting point for preparing the informed consent form. The IRB stamped and dated consent form should be used as a master to copy, and subjects may only be enrolled using informed consent form that have a valid “IRB Approval” stamp.
Assent Form [doc]
For research involving children, the assent of a child to participate in research is required whenever the child is capable of providing assent. The means for obtaining assent is based on the age, maturity, condition, and psychological/emotional state of the child. In many cases, written signed assent is not appropriate for children. In these cases, provision must be made to obtain assent through age appropriate means (e.g. oral script), In most instances not involving clinical interventions, the IRB recommends oral assent for children under twelve (12) years old.